Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

Status:	Completed
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any - 17
Updated:	2/8/2015
Start Date:	January 2015
End Date:	March 2015
Contact:	JoAnn Dyangko
Email:	jdyangko@otonomy.com

A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will
receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the
middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The
study is designed to characterize safety and any procedural issues associated with TTT drug
administration of OTO-201.

Inclusion Criteria includes, but is not limited to:

- Subject is a male or female aged 6 months to 17 years, inclusive

- Subject has a clinical diagnosis of bilateral middle ear effusion requiring
tympanostomy tube placement

- Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

- Subject has a history of prior ear or mastoid surgery, not including myringotomy or
myringotomy with tympanostomy tube placement

- Subject has a history of sensorineural hearing loss

- Subject has been designated for any other surgical procedure that would occur
concurrently with TT placement, such as, but not limited to adenoidectomy or
tonsillectomy

We found this trial at

sites

Piedmont Ear, Nose and Throat

Winston-Salem, North Carolina

from

Winston-Salem, NC